Evaluation of The Relationship Between Perioperative Hypothermia and Emergence Agitation

Recruiting

• Conditions: Hypothermia Following Anesthesia; Hypothermia; Anesthesia; Postoperative Complications; Agitation, Emergence
• Interventions: Procedure: surgery; Procedure: sedation scale

• Registration Number: NCT06543134
• Lead Sponsor: Kocaeli City Hospital

Brief Summary

The main aim of our study was to investigate the relationship between perioperative hypothermia and postoperative emergence agitation.

Detailed Description

Unintentional hypothermia during surgery is defined as a decrease in body temperature below 36.0 C in the preoperative period, 1 hour before anesthesia and within the first 24 hours after surgery (1).

Unintentional hypothermia during surgery is seen in most patients undergoing surgery. The incidence of perioperative hypothermia is expressed with different values in different studies, but it varies between 30% and 90% (2,3). Hypothermia has many negative effects on mortality and morbidity, such as increased hospital stay, increased perioperative bleeding, increased cardiac complications, delayed wound healing, and delayed recovery from anesthesia (4). It has been observed that these negative effects are seen even in mild hypothermia and that patients should take a more active role in preventing perioperative hypothermia (5). Risk factors for perioperative hypothermia include many factors such as prolonged surgery, advanced age, ASA score, gender, and intravenous fluid administration.

The mentioned negative situation is a negative situation. Recovery agitation was first described in the 1960s and is characterized by restlessness, crying, and poor cooperation (6). Recovery agitation may be severe in the first 30 minutes and then subside. During this time, it may lead to self-harm, disruption of surgical drains or dressings, increased bleeding and surgical complications, unintended early extubations, and an increase in falls and other similar complications in patients (7). Recovery agitation in pediatric patients is measured by the Pediatric Anesthesia Early Delirium Scale and in adult patients, usually by the Richmond Agitation Sedation Scale (8). The incidence of recovery agitation is approximately 20%, and its pathophysiology is not yet fully understood. Risk factors include age, gender, ASA physical status, type of surgery, anesthetic technique (inhalation or total intravenous), administration of neostigmine or doxapram, inadequate postoperative analgesia, pain, presence of a tracheal tube, and presence of a urinary catheter (9). In our literature review, we observed that the effects of perioperative hypothermia and core temperature changes on recovery agitation have not been sufficiently investigated. In this study, we aimed to investigate the relationship between perioperative hypothermia and recovery agitation in patients undergoing septoplasty/rhinoplasty, functional endoscopic sinus surgery (FESS), tympanoplasty, and mastoidectomy in otolaryngology operating rooms.

Study Timeline

• Study Start: 2024-03-01
• Status Verified: 2024-08
• Study First Submitted: 2024-08-03
• Study First Submitted QC: 2024-08-03
• Last Update Submitted: 2024-08-03
• Study First Posted: 2024-08-07
• Last Update Posted: 2024-08-07
• Primary Completion: 2024-08-30
• Study Completion: 2024-09-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Patients with informed consent Elective planned cases
• Patients between the ages of 18-65
• American Society of Anesthesiologists ASA classification ASA 1-2 patients
• Surgeries planned to last at least 30 minutes.

Exclusion Criteria

• Patients who refuse to participate in the study,
• patients who are considered for emergency surgery,
• pediatric patients,
• patients with peripheral vascular diseases or carotid stenosis,
• patients using antidepressants or antipsychotic drugs
• those with neurological diseases will be excluded from the study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group A	surgery	Patients who developed postoperative hypothermia were included in this group.
Group A	sedation scale	Patients who developed postoperative hypothermia were included in this group.
Group B	sedation scale	Patients who did not develop postoperative hypothermia were included in this group.
Group B	surgery	Patients who did not develop postoperative hypothermia were included in this group.

Primary Outcome Measures

Name	Time	Method
Relationship between hypothermia and emergence agitation	first postoperative hour	Comparison of recovery agitation rates in postoperative hypothermic and non-hypothermic patients

Secondary Outcome Measures

Name	Time	Method
Incidence of perioperative hypothermia	Between the first 1 hour preoperatively and the first 1 hour postoperatively	Incidence of hypothermia observed in the operating room and recovery room

Trial Locations

Locations (1)

Kocaeli City Hospital; 🇹🇷 Kocaeli, Izmit, Turkey